Gel-One

Gel-One (cross-linked hyaluronate) is an injectable hyaluronate gel approved for the treatment of osteoarthritis (OA) of the knee who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics, e.g., acetaminophen. Common side effects of Gel-One include:

• joint swelling or pain
• fluid buildup around the knee
• joint stiffness
• injection site reactions (pain, warmth, redness, bruising, itching)
• arthritis, and
• changes in gait

Gel-One Hyaluronate is packaged in a single-injection dose, 3mL syringe (1% solution [10 mg/mL], 30mg total hyaluronan). It is injected into the intra-articular space of the knee. Gel-One may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or breastfeeding before receiving Gel-One.

Our Gel-One (cross-linked hyaluronate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Gel-One Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe pain or swelling around the knee after the injection.

Common side effects may include:

• warmth, pain, redness, stiffness, bruising, or puffiness where the medicine was injected;
• nausea, stomach pain;
• trouble walking;
• swelling in your hands or feet;
• back pain, joint pain, muscle pain;
• numbness or tingly feeling;
• headache, dizziness; or
• runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Gel-One (Cross-Linked Hyaluronate Viscoelastic Hydrogel)

 

Gel-One Professional Information

SIDE EFFECTS

Adverse Events

Reported Device-Related Adverse Events

The most common adverse events related to Gel-One® injection reported in the clinical study are the following:

• Joint swelling
• Joint effusion
• Arthralgia

All adverse events related to Gel-One® injection reported in the clinical study are provided in the Adverse Events Summary.

Potential Adverse Events

The following adverse events are among those that may occur in association with intra-articular injections.

• Arthralgia
• Joint stiffness
• Joint effusion
• Joint swelling
• Joint warmth
• Injection site pain
• Arthritis
• Arthropathy
• Gait disturbance

According to post-marketing experience of other sodium hyaluronate preparations, anaphylactic/ anaphylactoid reactions accompanied by transient hypotension (sudden drop in blood pressure), have been rarely reported worldwide, all of which resolved either spontaneously or after conservative treatment.

Read the entire FDA prescribing information for Gel-One (Cross-Linked Hyaluronate Viscoelastic Hydrogel)